About the position
The Technical Writer position at InstantServe LLC in San Jose, CA, is a contract role focused on the development and maintenance of technical documentation for medical devices, specifically in vitro diagnostics (IVD) or related fields. The successful candidate will be responsible for creating a variety of documents that adhere to organizational standards, including standard operating procedures (SOPs), design specifications, study protocols, and user manuals. This role requires a strong understanding of the regulatory landscape, particularly FDA regulations, and the ability to produce high-quality documentation that meets compliance requirements. In this position, the Technical Writer will coordinate change requests within the change management process for research and development, ensuring that all documentation reflects the latest specifications and labeling requirements. The role also involves reviewing and auditing technical publications to maintain quality standards. As regulations evolve and quality systems are integrated, the Technical Writer will be tasked with refining existing documentation and creating new materials as needed. Collaboration is key in this role, as the Technical Writer will work closely with cross-functional teams to gather necessary information and ensure that all documentation is accurate, complete, and consistent. The position also includes managing the review and approval process for technical documents, ensuring that they are accessible to all stakeholders and compliant with regulatory standards. Additionally, the Technical Writer will assist in developing and implementing documentation standards and policies, providing weekly summaries of activities, and creating project plans to prioritize tasks effectively. The ideal candidate will have a background in engineering or science, with a minimum of three years of experience in technical writing for medical device development. Proficiency in documentation tools such as Adobe Acrobat and experience with electronic document management systems are essential. Strong communication skills, attention to detail, and the ability to manage multiple projects simultaneously are critical for success in this role.
Responsibilities
- Develop and maintain technical documentation that meets organizational standards, including standard operating procedures, design specifications, study protocols, and user manuals.
- Coordinate change requests within the change management process for R&D, including changes in specifications, labeling, and SOPs.
- Review and audit other technical publications deliverables to ensure quality documentation.
- Execute the creation and refinement of documentation as regulations change and quality systems are merged.
- Create end-user regulatory compliant product labeling.
- Contribute to new product development and design change activities, including labeling design/release and technical writing.
- Collaborate with cross-functional teams to gather information and ensure documentation accuracy and completeness.
- Manage the review and approval process for all technical documentation to ensure compliance with regulatory requirements.
- Ensure documentation is up-to-date, accurate, and accessible to all stakeholders.
- Assist in the development and implementation of documentation standards, policies, and procedures.
- Provide weekly summaries of activities and create project plans for assigned tasks, prioritizing effectively and communicating updates to customers.
- Follow Good Document Practices (GDP) for all documentation created/reviewed and stay current on all required training.
Requirements
- Bachelor's degree or Master's in engineering, science, or a related field.
- 3-5 years of experience in technical writing for medical device development of complex systems including hardware, software, and reagents.
- Experience working in a regulated industry such as FDA or ISO.
- Experience with electronic document management software (Livelink or similar) for tracking and processing document change requests.
- Experience with Quality Management Systems.
- Experience with Product Development and Design Control Processes.
- Proficient in documentation tools such as Office, Adobe Acrobat, and content management systems.
- Excellent written and verbal communication skills with the ability to effectively communicate technical information to a variety of audiences.
- Strong attention to detail and accuracy.
- Ability to work collaboratively in a cross-functional team environment.
- Ability to prioritize and manage multiple projects simultaneously.
